Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

NCT00021294 | Completed Phase 2

• 4 other identifiers: CDR0000068767P01CA027502UARIZ-HSC-0072NCI-H01-0075
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis.

Conditions

Non-melanomatous Skin Cancer; Precancerous/Nonmalignant Condition

Keywords

basal cell carcinoma of the skin; squamous cell carcinoma of the skin; actinic keratosis

Interventions

eflornithine DRUG

triamcinolone DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Diagnosis of actinic keratosis At least 3 clinically visible lesions on each lower posterior forearm Lesions must be discrete and quantifiable No prior or concurrent skin cancer on forearms Prior skin cancer (other than melanoma) on an area other than the forearms allowed unless chronic recurrent lesions indicate immunosuppression Concurrent skin cancer on an area other than the forearms allowed if active lesion previously excised PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious concurrent illness No immunosuppression due to medication or disease No invasive cancer (including melanoma) within the past 5 years Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 28 days prior to and during study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior systemic chemotherapy At least 6 months since prior fluorouracil (5-FU) to forearms Prior or concurrent 5-FU to the face allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior megadoses of vitamins (e.g., more than 400 IU of vitamin E, 200 micrograms of selenium, or 1 g of vitamin C per day or more than the tolerable upper limits of any other supplement) At least 6 months since prior tretinoin to forearms Prior or concurrent tretinoin to the face allowed No concurrent mega-doses of vitamins No other concurrent investigational drug or device

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Precancerous Conditions; Carcinoma, Basal Cell; Keratosis, Actinic

Interventions

Eflornithine; Triamcinolone

Condition Hierarchy (Ancestors)

Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• David S. Alberts, MD

  University of Arizona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: February 16, 2004
• Study Start: May 1, 2001
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (1)